On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. According to Genentech, LN occurs in up to 60% of people with lupus and can lead to permanent kidney damage and even kidney failure if not effectively treated.
The approval was supported by positive results from the Phase II NOBILITY and Phase III REGENCY trials. In the REGENCY trial, 46.4% of patients receiving GAZYVA alongside standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response—defined as restored kidney function—compared to those receiving standard therapy alone.